Monopolar Electrode Surgical Instrument

K230650 · Vhmed (Nantong) Co. , Ltd. · GEI · Oct 12, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K230650
• Device Name: Monopolar Electrode Surgical Instrument
• Applicant: Vhmed (Nantong) Co. , Ltd.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 12, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is a family of instruments which includes scissors, probes and forceps which are intended to be used in general laparoscopic surgical procedures requiring the use of Monopolar Electrosurgical cutting and/or coagulation.

Device Story

Family of sterile, single-use laparoscopic instruments including scissors, probes, and forceps; used in general laparoscopic surgery. Device consists of conductive jaw tip, insulated shaft, and conductive post; connects to electrosurgical generator via cable. Operated by surgeons in clinical settings to cut, dissect, manipulate, or cauterize tissue. Output is electrical energy delivered to tissue for cutting or coagulation. Benefits include precise tissue management during minimally invasive procedures.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including biocompatibility (ISO 10993-5, -10, -11), electrical safety (IEC 60601-1, -2-2, -2-18, -1-2), and sterilization validation.

Technological Characteristics

Monopolar electrosurgical instruments; conductive jaw tips, insulated shafts. Energy source: external electrosurgical generator. Dimensions: 3mm and 5mm diameters; lengths 200mm-450mm. Sterilization: Ethylene Oxide (EO). Standards: ISO 10993 (biocompatibility), IEC 60601 series (electrical safety).

Indications for Use

Indicated for use in general laparoscopic surgical procedures requiring monopolar electrosurgical cutting and/or coagulation. No specific patient population age or gender restrictions are stated.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• Monopolar Laparoscopic Accessories (K142208)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA part of the logo is in blue.

October 12, 2023

VHMED (Nantong) Co. Ltd. % Jun Peng Principal Consultant P&L Scientific, Inc. 1430 S. Dixie Hwy Suite 105 Coral Gables, Florida 33146

Re: K230650

Trade/Device Name: Monopolar Electrode Surgical Instrument Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: September 12, 2023 Received: September 12, 2023

Dear Jun Peng:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone [phone] or 301-796-7100).

Sincerely.

Long H. Chen -S Digitally signed by Long H. Chen-S
Date: 2023.10.12 13:24:14 -04'00'

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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## Indications for Use

510(k) Number (if known) K230650

Device Name Monopolar Electrode Surgical Instrument

Indications for Use (Describe)

The device is a family of instruments which includes scissors, probes and forceps which are intended to be used in general laparoscopic surgical procedures requiring the use of Monopolar Electrosurgical cutting and/or coagulation.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image is a logo for VHIMED, a company that specializes in laparoscopy. The logo is green and features the company name in a stylized font. Below the company name is the tagline "Excellence in Laparoscopy". The logo is simple and modern, and it conveys a sense of professionalism and expertise.

## 510(k) Summary

This 510(k) summary is being submitted in accordance with 21 CFR §807.92.

## 1. Applicant/Submitter

VHMED (Nantong) Co. Ltd.

Address: A1, 173 Ganjiang Road, Tongzhou Bay, Jiangsu, 226332 China

Tel: [phone]

Fax: [phone]

E-mail: [e-mail]

### 2. Submission Contact Person

Mr. Jun Peng

Address: P&L SCIENTIFIC, INC.

1430 S. Dixie Hwy STE 105, Coral Gables, FL 33146

Tel: [phone]

Fax: [phone]

E-mail: [e-mail]

### 3. Subject Device

Trade Name: Monopolar Electrode Surgical Instrument

Common Name: Laparoscopic Instrument and Accessory

Classification Name: Electrosurgical, Cutting & Coagulation & Accessories

Classification Requlation Number: 878.4400

Device Class: II

Product Code: GEI

### 4. Predicate Device

Table 1. Predicative Device Information

| Manufacturer | Device Name | 510(k) Number |
|-------------------------------------------------|---------------------------------------|---------------|
| Unimicro Medical<br>Systems(Shenzhen) Co., Ltd. | Monopolar Laparoscopic<br>Accessories | K142208 |

Page 1 of 9

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Image /page/4/Picture/0 description: The image shows the logo for VHMED, a company that specializes in laparoscopy. The logo is green and features the letters "VHMED" in a stylized font. Below the logo, the words "Excellence in Laparoscopy" are written in a smaller font. The logo is simple and modern, and it conveys the company's focus on quality and innovation.

#### 5. Device Description

The Monopolar Electrode Surgical Instrument is a kind of device used to cut, dissect, manipulate and/or cauterize various tissues during endoscopic/laparoscopic, general surgical procedures. The Monopolar Electrode Surgical Instrument is provided sterile when they're released. The device consists of a conductive jaw tip, an insulated shaft and a conductive post which allows it can be connected through an appropriate cable to an electrosurgical generator. The device is available with different handles and different tip designs.

#### 6. Product Specification

#### Table A. Models and Specifications for Monopolar Scissors

| Device Name: Monopolar Electrode Surgical Instrument | | |
|------------------------------------------------------|------------------------------------------------------------------|---------------|
| Jaw Tip Family: Scissors | | |
| Model | Device Description | Specification |
| LS1001S | Monopolar Curved Metzenbaum Scissors, insulation to the tip | Φ5*250mm |
| LS1001 | Monopolar Curved Metzenbaum Scissors, insulation to the tip | Φ5*330mm |
| LS1001L | Monopolar Curved Metzenbaum Scissors, insulation to the tip | Φ5*450mm |
| LS1002S | Monopolar Curved Metzenbaum Scissors | Φ5*250mm |
| LS1002 | Monopolar Curved Metzenbaum Scissors | Φ5*330mm |
| LS1002L | Monopolar Curved Metzenbaum Scissors | Φ5*450mm |
| LS1003S | Monopolar Curved Mini Metzenbaum Scissors, insulation to the tip | Φ5*250mm |
| LS1003 | Monopolar Curved Mini Metzenbaum Scissors, insulation to the tip | Φ5*330mm |
| LS1003L | Monopolar Curved Mini Metzenbaum Scissors, insulation to the tip | Φ5*450mm |
| LS1004S | Monopolar Straight Metzenbaum Scissors | Φ5*250mm |
| LS1004 | Monopolar Straight Metzenbaum Scissors | Φ5*330mm |
| LS1004L | Monopolar Straight Metzenbaum Scissors | Φ5*450mm |
| LS1041S | Articulating Curved Metzenbaum Scissors | Φ5*250mm |
| LS1041 | Articulating Curved Metzenbaum Scissors | Φ5*330mm |
| LS1041L | Articulating Curved Metzenbaum Scissors | Φ5*450mm |
| LS6001S | Monopolar Curved Metzenbaum Scissors, insulation to the tip | Φ3*200mm |
| LS6001 | Monopolar Curved Metzenbaum Scissors, insulation to the tip | Φ3*280mm |
| LS6001L | Monopolar Curved Metzenbaum Scissors, insulation to the tip | Φ3*340mm |

Table B. Models and Specifications for Monopolar Dissecting Forceps

Device Name: Monopolar Electrode Surgical Instrument Jaw Tip Family: Dissecting Forceps

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Image /page/5/Picture/0 description: The image shows the VH-MED logo. The logo is in green and consists of the letters "VH-MED" in a stylized font. Below the logo, the words "Excellence in Laparoscopy" are written in a smaller font, also in green. The logo appears to be for a medical company or organization specializing in laparoscopic procedures.

| Model | Device Description | Specification |
|---------|---------------------------------------|---------------|
| LS1011S | Monopolar Maryland Dissector | $Ф5*250mm$ |
| LS1011 | Monopolar Maryland Dissector | $Ф5*330mm$ |
| LS1011L | Monopolar Maryland Dissector | $Ф5*450mm$ |
| LS1012S | Monopolar Modified Maryland Dissector | $Ф5*250mm$ |
| LS1012 | Monopolar Modified Maryland Dissector | $Ф5*330mm$ |
| LS1012L | Monopolar Modified Maryland Dissector | $Ф5*450mm$ |
| LS1042S | Articulating Maryland Dissector | $Ф5*250mm$ |
| LS1042 | Articulating Maryland Dissector | $Ф5*330mm$ |
| LS1042L | Articulating Maryland Dissector | $Ф5*450mm$ |
| LS6011S | Monopolar Maryland Dissector | $Ф3*200mm$ |
| LS6011 | Monopolar Maryland Dissector | $Ф3*280mm$ |
| LS6011L | Monopolar Maryland Dissector | $Ф3*340mm$ |

Table C. Models and Specifications for Monopolar Grasping Forceps

| Device Name: Monopolar Electrode Surgical Instrument | | |
|------------------------------------------------------|-----------------------------------------------------|---------------|
| Jaw Tip Family: Grasping Forceps | | |
| Model | Device Description | Specification |
| LS1021S | Monopolar Fenestrated Johann Grasper | Ф5*250mm |
| LS1021 | Monopolar Fenestrated Johann Grasper | Ф5*330mm |
| LS1021L | Monopolar Fenestrated Johann Grasper | Ф5*450mm |
| LS1022S | Monopolar Long Jaw Fenestrated Johann Grasper | Ф5*250mm |
| LS1022 | Monopolar Long Jaw Fenestrated Johann Grasper | Ф5*330mm |
| LS1022L | Monopolar Long Jaw Fenestrated Johann Grasper | Ф5*450mm |
| LS1023S | Monopolar Extra Long Jaw Fenestrated Johann Grasper | Ф5*250mm |
| LS1023 | Monopolar Extra Long Jaw Fenestrated Johann Grasper | Ф5*330mm |
| LS1023L | Monopolar Extra Long Jaw Fenestrated Johann Grasper | Ф5*450mm |
| LS1024S | Monopolar Blunt Tip Atraumatic Grasper | Ф5*250mm |
| LS1024 | Monopolar Blunt Tip Atraumatic Grasper | Ф5*330mm |
| LS1024L | Monopolar Blunt Tip Atraumatic Grasper | Ф5*450mm |
| LS1025S | Monopolar Clinch Grasper | Ф5*250mm |
| LS1025 | Monopolar Clinch Grasper | Ф5*330mm |
| LS1025L | Monopolar Clinch Grasper | Ф5*450mm |
| LS1026S | Monopolar Rat Tooth Claw Grasper | Ф5*250mm |
| LS1026 | Monopolar Rat Tooth Claw Grasper | Ф5*330mm |
| LS1026L | Monopolar Rat Tooth Claw Grasper | Ф5*450mm |
| LS1027S | Monopolar Babcock Grasper | Ф5*250mm |
| LS1027 | Monopolar Babcock Grasper | Ф5*330mm |
| LS1027L | Monopolar Babcock Grasper | Ф5*450mm |
| LS1028S | Monopolar Allis Grasper | Ф5*250mm |
| Device Name: Monopolar Electrode Surgical Instrument | | |
| | Jaw Tip Family: Grasping Forceps | |
| Model | Device Description | Specification |
| LS1028 | Monopolar Allis Grasper | Φ5*330mm |
| LS1028L | Monopolar Allis Grasper | Φ5*450mm |
| LS1029S | Monopolar Duckbill Grasper | Φ5*250mm |
| LS1029 | Monopolar Duckbill Grasper | Φ5*330mm |
| LS1029L | Monopolar Duckbill Grasper | Φ5*450mm |
| LS1030S | Monopolar Wave Teeth Grasper | Φ5*250mm |
| LS1030 | Monopolar Wave Teeth Grasper | Φ5*330mm |
| LS1030L | Monopolar Wave Teeth Grasper | Φ5*450mm |
| LS1043S | Articulating Monopolar Johann Fenestrated Grasper | Φ5*250mm |
| LS1043 | Articulating Monopolar Johann Fenestrated Grasper | Φ5*330mm |
| LS1043L | Articulating Monopolar Johann Fenestrated Grasper | Φ5*450mm |
| LS1044S | Articulating Clinch Grasper | Φ5*250mm |
| LS1044 | Articulating Clinch Grasper | Φ5*330mm |
| LS1044L | Articulating Clinch Grasper | Φ5*450mm |
| LS6021S | Monopolar Johann Fenestrated Grasper | Φ3*200mm |
| LS6021 | Monopolar Johann Fenestrated Grasper | Φ3*280mm |
| LS6021L | Monopolar Johann Fenestrated Grasper | Φ3*340mm |
| LS6022S | Monopolar Long Jaw Fenestrated Johann Grasper | Φ3*200mm |
| LS6022 | Monopolar Long Jaw Fenestrated Johann Grasper | Φ3*280mm |
| LS6022L | Monopolar Long Jaw Fenestrated Johann Grasper | Φ3*340mm |
| LS6023S | Monopolar Extra Long Jaw Fenestrated Johann Grasper | Φ3*200mm |
| LS6023 | Monopolar Extra Long Jaw Fenestrated Johann Grasper | Φ3*280mm |
| LS6023L | Monopolar Extra Long Jaw Fenestrated Johann Grasper | Φ3*340mm |
| LS6024S | Monopolar Blunt Tip Atraumatic Grasper | Φ3*200mm |
| LS6024 | Monopolar Blunt Tip Atraumatic Grasper | Φ3*280mm |
| LS6024L | Monopolar Blunt Tip Atraumatic Grasper | Φ3*340mm |
| LS6025S | Monopolar Clinch Grasper | Φ3*200mm |
| LS6025 | Monopolar Clinch Grasper | Φ5*280mm |
| LS6025L | Monopolar Clinch Grasper | Φ5*340mm |
| LS6026S | Monopolar Rat Tooth Claw Grasper | Φ3*200mm |
| LS6026 | Monopolar Rat Tooth Claw Grasper | Φ3*280mm |
| LS6026L | Monopolar Rat Tooth Claw Grasper | Φ3*340mm |
| LS6027S | Monopolar Babcock Grasper | Φ3*200mm |
| LS6027 | Monopolar Babcock Grasper | Φ3*280mm |
| LS6027L | Monopolar Babcock Grasper | Φ3*340mm |
| LS6028S | Monopolar Allis Grasper | Φ3*200mm |
| Device Name: Monopolar Electrode Surgical Instrument | | |
| Jaw Tip Family: Grasping Forceps | | |
| Model | Device Description | Specification |
| LS6028 | Monopolar Allis Grasper | Φ3*280mm |
| LS6028L | Monopolar Allis Grasper | Φ3*340mm |
| LS6029S | Monopolar Duckbill Grasper | Φ3*200mm |
| LS6029 | Monopolar Duckbill Grasper | Φ3*280mm |
| LS6029L | Monopolar Duckbill Grasper | Φ3*340mm |
| LS6030S | Monopolar Wave Teeth Grasper | Φ3*200mm |
| LS6030 | Monopolar Wave Teeth Grasper | Φ3*280mm |
| LS6030L | Monopolar Wave Teeth Grasper | Φ3*340mm |

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006_VH-FD001-01 510(k) Summary

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Image /page/6/Picture/0 description: The image shows the logo for VH-MED, a company that specializes in laparoscopy. The logo is a green color and features the company name in a stylized font. Below the logo is the tagline "Excellence in Laparoscopy".

Page 4 of 9 006_VH-FD001-01 510(k) Summary

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Image /page/7/Picture/0 description: The image is a logo for VH-MED, a company that specializes in excellence in laparoscopy. The logo is green and features the letters "VH-MED" in a stylized font. The words "Excellence in Laparoscopy" are written in a smaller font below the logo. The logo is simple and modern, and it conveys the company's focus on quality and innovation.

## Table D. Models and Specifications for Monopolar Electrodes

| Model | Device Description | Specification |
|----------|--------------------------------------------------------|---------------|
| LS1031S | L Hook Coagulation Electrode | Φ5*250mm |
| LS1031 | L Hook Coagulation Electrode | Φ5*330mm |
| LS1031C | L Hook Coagulation Electrode, with Cable | Φ5*330mm |
| LS1031L | L Hook Coagulation Electrode | Φ5*450mm |
| LS1031LC | L Hook Coagulation Electrode, with Cable | Φ5*450mm |
| LS1032S | J Hook Coagulation Electrode | Φ5*250mm |
| LS1032 | J Hook Coagulation Electrode | Φ5*330mm |
| LS1032L | J Hook Coagulation Electrode | Φ5*450mm |
| LS1033S | Scalpel Coagulation Electrode | Φ5*250mm |
| LS1033 | Scalpel Coagulation Electrode | Φ5*330mm |
| LS1033L | Scalpel Coagulation Electrode | Φ5*450mm |
| LS1034S | Ball Coagulation Electrode | Φ5*250mm |
| LS1034 | Ball Coagulation Electrode | Φ5*330mm |
| LS1034L | Ball Coagulation Electrode | Φ5*450mm |
| LS1035S | Scoop Coagulation Electrode | Φ5*250mm |
| LS1035 | Scoop Coagulation Electrode | Φ5*330mm |
| LS1035L | Scoop Coagulation Electrode | Φ5*450mm |
| LS1036S | Needle Coagulation Electrode | Φ5*250mm |
| LS1036 | Needle Coagulation Electrode | Φ5*330mm |
| LS1036L | Needle Coagulation Electrode | Φ5*450mm |
| LS1038S | L Hook Coagulation Electrode, with Extended Insulation | Φ5*250mm |
| LS1038 | L Hook Coagulation Electrode, with Extended Insulation | Φ5*330mm |
| LS1038L | L Hook Coagulation Electrode, with Extended Insulation | Φ5*450mm |
| LS1045S | Articulating Hook Coagulation Electrode | Φ5*250mm |

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006_VH-FD001-01 510(k) Summary

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Image /page/8/Picture/0 description: The image is a logo for VH-MED, a company that specializes in laparoscopy. The logo is green and features the company name in a stylized font. Below the company name is the tagline "Excellence in Laparoscopy". The logo is simple and modern, and it conveys the company's focus on quality and innovation.

| Device Name: Monopolar Electrode Surgical Instrument | | |
|------------------------------------------------------|-----------------------------------------|---------------|
| Jaw Tip Family: Electrodes | | |
| Model | Device Description | Specification |
| LS1045 | Articulating Hook Coagulation Electrode | Φ5*330mm |
| LS1045L | Articulating Hook Coagulation Electrode | Φ5*450mm |
| LS6031S | L Hook Coagulation Electrode | Φ3*200mm |
| LS6031 | L Hook Coagulation Electrode | Φ3*280mm |
| LS6031L | L Hook Coagulation Electrode | Φ3*340mm |
| LS6032S | J Hook Coagulation Electrode | Φ3*200mm |
| LS6032 | J Hook Coagulation Electrode | Φ3*280mm |
| LS6032L | J Hook Coagulation Electrode | Φ3*340mm |
| LS6033S | Scalpel Coagulation Electrode | Φ3*200mm |
| LS6033 | Scalpel Coagulation Electrode | Φ3*280mm |
| LS6033L | Scalpel Coagulation Electrode | Φ3*340mm |
| LS6034S | Ball Coagulation Electrode | Φ3*200mm |
| LS6034 | Ball Coagulation Electrode | Φ3*280mm |
| LS6034L | Ball Coagulation Electrode | Φ3*340mm |
| LS6035S | Scoop Coagulation Electrode | Φ3*200mm |
| LS6035 | Scoop Coagulation Electrode | Φ3*280mm |
| LS6035 | Scoop Coagulation Electrode | Φ3*340mm |
| LS6036S | Needle Coagulation Electrode | Φ3*200mm |
| LS6036 | Needle Coagulation Electrode | Φ3*280mm |
| LS6036L | Needle Coagulation Electrode | Φ3*340mm |

## 7. Intended Use/Indications for Use

The device is a family of instruments which includes scissors, probes and forceps which are intended to be used in general laparoscopic surgical procedures requiring the use of Monopolar Electrosurgical cutting and/or coagulation.

### 8. Substantial Equivalence

8.1 Comparison between Monopolar Electrode Surgical Instrument and K142208

| Item | Subject Device<br>Monopolar Electrode<br>Surgical Instrument | Predicate Device<br>Monopolar Laparoscopic<br>Accessories | Result |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Regulation No. | 878.4400 | 878.4400 | Same |
| Regulation<br>Class | II | II | Same |
| Item | Subject Device<br>Monopolar Electrode<br>Surgical Instrument | Predicate Device<br>Monopolar Laparoscopic<br>Accessories | Result |
| Product Code | GEI | GEI | Same |
| Models | Forceps: Grasper<br>Babcock Forceps<br>Clinch Forceps<br>Rat Tooth Forceps<br>Johan Forceps<br>Duckbill Forceps<br>Dissector Forceps<br>Scissors | Forceps: Grasper<br>Babcock Forceps<br>Clinch Forceps<br>Rat Tooth Forceps<br>Dissector Forceps<br>Scissors | Similar |
| | Electrodes:<br>Monopolar J Hook<br>Coagulation Electrode<br>Monopolar L Hook<br>Coagulation Electrode | Electrodes:<br>Monopolar J Hook Probe<br>Monopolar L Hook Probe | |
| Intended<br>Use/Indications<br>for Use | The device is a family of<br>instruments which<br>includes scissors, probes<br>and forceps which are<br>intended to be used in<br>general laparoscopic<br>surgical procedures<br>requiring the use of<br>Monopolar Electrosurgical<br>cutting and/or<br>coagulation. | The device is a family of<br>instruments which<br>includes scissors, probes<br>and forceps which are<br>intended to be used in<br>general laparoscopic<br>surgical procedures<br>requiring the use of<br>Monopolar Electrosurgical<br>cutting and/or<br>coagulation. | Same |
| Operation Mode | Devices are either monopolar endoscopic instruments for tissue manipulation and cutting/coagulation, or non-powered endoscopic instruments for tissue manipulation dissection and cutting. | Devices are either monopolar endoscopic instruments for tissue manipulation and cutting/coagulation, or non-powered endoscopic instruments for tissue dissection manipulation and cutting. | Same |
| Structure | Handle, shaft and jaw tips | Handle, shaft and jaw tips | Same |
| Shaft Length | 200mm/280mm/340mm<br>250mm/330mm/450mm | 330mm | Similar |
| Item | Subject Device<br>Monopolar Electrode<br>Surgical Instrument | Predicate Device<br>Monopolar Laparoscopic<br>Accessories | Result |
| Sterilization | EO | EO | Same |
| Single Use | Yes | Yes | Same |
| Biocompatibility | ISO 10993-5<br>ISO 10993-10<br>ISO 10993-11 | ISO 10993-5<br>ISO 10993-10<br>ISO 10993-11 | Same |
| Meets the IEC<br>60601-2-2 | Yes | Yes | Same |

Table 2. Comparison to K142208

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Image /page/9/Picture/0 description: The image is a logo for VHIMED, a company that specializes in laparoscopy. The logo is green and features the company name in a stylized font. Below the company name is the tagline "Excellence in Laparoscopy." The logo is simple and modern, and it conveys the company's focus on quality and innovation.

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Image /page/10/Picture/0 description: The image is a logo for VHIMED, a company that specializes in laparoscopy. The logo is green and features the company name in a stylized font. Below the company name is the tagline "Excellence in Laparoscopy". The logo is simple and professional, and it conveys the company's focus on quality and expertise.

## 9. Performance Data

Verification and verification results demonstrate that the device performs as intended and that the device is substantially equivalent to the predicate devices K142208.

## 9.1 Biocompatibility

The biocompatibility tests were performed in accordance with the FDA recognized standards:

- l ISO 10993-5:2009, Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity
- -ISO 10993-10:2010, Biological evaluation of medical devices —Part 10: Tests for skin sensitization and irritation
- -ISO 10993-11:2017, Biological evaluation of medical devices-Part 11: Tests for systemic toxicity

9.2 Electrical Safety

The devices subject to this submission have been tested according to the requirements of IEC 60601-1, IEC 60601-2-2, IEC 60601-2-18 and IEC 60601-1-2.

9.3 Sterility

The sterilization process has been validated under consideration of recognized standards. Testing shows that the products can be EO sterilized with a sufficient

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Image /page/11/Picture/0 description: The image is a logo for VHMED, a company that specializes in laparoscopy. The logo is green and features the letters "VHMED" in a stylized font. Below the letters, the words "Excellence in Laparoscopy" are written in a smaller font. The logo is simple and modern, and it conveys the company's focus on quality and innovation in the field of laparoscopy.

sterility assurance level of 10-6 by use of standard sterilization parameters.

9.4 Packing and Shelf Life

The shelf life about the Monopolar Electrode Surgical Instrument is 3 years. The shelf life period for the device was determined through an analysis of the shelf-life stability of the materials used in the design of the device, as well as an analysis of the packaging materials and processes.

### 10. Clinical Testing

Substantial equivalence does not depend on clinical test data.

### 11. Substantial Equivalence Summary/Conclusion

Based on device comparison information and non-clinical testing, the differences between Monopolar Electrode Surgical Instrument and predicate devices will not raise any new issues of safety and effectiveness. Monopolar Electrode Surgical Instrument is substantially equivalent to legally marketed predicate devices.